MA is involved in several areas relating to ESG where direct influence can be exerted and responsibilities assumed, carrying the potential for corporate integration of the function to be included in ESG strategies. These areas are depicted in Fig. 1 and will be described in more detail in the subsequent sections for each determinant of ESG.

2.1 Environment

The impact of global warming necessitates a heightened focus and sense of urgency on the environmental impact of the pharmaceutical industry [17]. The US has the second highest carbon dioxide (CO2) emission in the world, after China and followed by India, Russia, and Japan [18]. On 27 January 2021, the White House issued an executive order to tackle the climate crisis at home and abroad, highlighting a narrow window to prevent the most dramatic impact of the climate crisis, which was followed by the Inflation Reduction Act in August 2022, setting an ambitious target for greenhouse gas (GHG) emission reduction and drawing the attention on the importance of environmental sustainability across different industries [19, 20].

2.1.1 Environmental Responsibilities of Pharmaceutical Companies

Pharmaceutical companies focus their environmental efforts on several pillars. To reduce and ultimately achieve net neutrality in direct and indirect GHG emissions through focus on renewable energy resources, reduce and achieve zero waste to landfill through recycling, use of products made from recycled material, equitable water use, and convert to an electric vehicle fleet [13].

It should not be forgotten that the use of electric vehicles alone is not sufficient to reduce GHG emissions. It does matter which source the electricity for said vehicles comes from, thereby highlighting the importance on renewable energy sources [21]. Furthermore, energy-saving measures for company infrastructure, such as energy-efficient buildings, e.g., via improved insulation, low energy-consuming lights such as LED lights, reduction of air-conditioning through automatic shades, and a highly effective supply chain using as little packaging material as possible, are some of the initiatives taken by companies [13].

Travel, especially air travel, comprises the biggest part of the environmental impact of companies’ activities. A recent study investigating industry congress travel of a mid-sized pharmaceutical company demonstrated that carbon emissions associated with in-person attendance resulted in 182 times the average emission per attendee compared with virtual attendance (mean 1893.5 kgCO2e vs. 10.4 kgCO2e), mainly due to air travel [22]. Reducing the requirement for air travel would be a first step towards reducing the carbon footprint. Looking for venues that can provide other options for travel (e.g., via trains) and selecting locations that are closer to participants and provide opportunities for virtual attendance are potential solutions [23]. Incorporating geography into the meeting location selection process and alternating large national-level meetings with smaller regional meetings may also reduce the environmental impact of medical meetings [24,25,26].

Reducing the environmental impact of travel refers not only to medical meetings but also field MA activities. Reducing the number of flights, encouraging the use of public transport and company policies for the purchase of hybrid or electric vehicles for field medical personnel (e.g., ‘Green Fleet’ programs) can efficiently reduce the environmental impact [27].

Besides travel, there are other ways to make MA activities, including events and other stakeholder engagement activities, more sustainable. Any educational event must be planned carefully, and venues with good recycling and emission reduction programs (including green-energy purchases) are preferred [27, 28]. Sustainability also applies to food and beverage choices, the use of carefully selected local and seasonal products, the reduction and supplementation of beef meat and dairy products. Beef production in particular is emission intensive, and beef has one of the largest GHG footprints among food products [29]. Reducing and replacing meat with vegetables and salad decreases food waste and also make meals less calorie-intense and decreases the risk of several non-communicable diseases, such as overweight, diabetes, coronary heart disease or cancer [30]. Smaller servings, as well as local produce and vegan or vegetarian meals, reduce food waste and reduce GHG emission due to the proximity of the food source [27, 31, 32].

2.1.2 Virtual Meetings and Massive Open Online Courses

The number of conferences with new formats is on the rise [33]. The coronavirus disease 2019 (COVID-19) pandemic prompted event holders to move conferences online. Virtual and hybrid conferences are greener alternatives to in-person conferences. A recent study found that moving from face-to-face to virtual events can decrease the carbon footprint by 94% and energy use by 90% [28]. However, an exclusively online format may result in lower involvement from participants and participation at conference social events [34]. Selected hubs for hybrid conferences may overcome reduced virtual engagement and have a potential to slash carbon footprint and energy, with spatially optimal hub selection reducing carbon footprint and energy consumption by 60–70% while maintaining 50% virtual participation [38].

High-level continuous medical education (CME) is essential to achieve optimal patient outcomes [15, 35]. As webinars are the most common forms of virtual CME activities, there is also a trend for massive open online courses (MOOCs) that have the functionality for learners to ask questions, discuss data and different practices, and network with fellow learners, therefore having a great potential to reduce the number of carbon-intensive live educational activities [36].

2.1.3 Increase Sustainability of Clinical Research

According to the Edinburgh Centre for Carbon Management, in the case of clinical studies, the carbon emission associated with clinical research may add up to 14 tons per employee involved each year compared with the 4–5 tons average among service industries [37].

An example to illustrate the impact of a clinical study on carbon emissions is the CRASH trial, which was conducted in 49 countries and required a complex drug distribution protocol [38]. In CRASH, total carbon emission was estimated for 1 year according to the World Business Council for Sustainable Development criteria [39]. During the audit period, 126 tons of GHGs (CO2 equivalents) were emitted. The main sources of energy use were the coordinating and research premises and air travel related to drug dissemination and business travel [37]. The CRASH study highlights the importance of manufacturing facilities and coordinating centers in the environmental impact of the clinical development process.

There are several options to reduce the environmental impact of clinical trials. Foremost, companies should avoid the collection of unnecessary data—sound justification is necessary for any new research activity. It is important to employ the minimally necessary study personnel and reduce unnecessary bureaucracy. Simple study protocols may reduce the need for site visits and building a local capacity and a network of triallists may also reduce the need for onsite training. Videoconferences/telemedicine and electronic remote data collection have also demonstrated environmental benefit [37, 40].

The role of MA has evolved to become an integral part of the drug development process, ranging from proof-of-concept to lifecycle management of a pharmaceutical [41]. As such, the MA function is no longer limited to postmarketing observational studies, and by being integrated into study designing and protocol development of clinical trials, has an opportunity to influence environmental considerations.

2.2 Social

The social pillar is a traditional key focus for pharma and healthcare companies, given their high degree of social responsibility to the public through the products made available to treat illnesses [42]. According to an analysis of 32 pharma and life science companies’ websites and 90 press releases between 1 January 2020, and 15 April 2021, 77% of pharma ESG efforts were social-related priorities, while just 12% were environmental and 11% were governance [43, 44].

MA plays a role in pharmaceutical enterprises when it comes to social responsibility and social-focused activities. This is because of several strategies the function is driving or heavily involved in, such as patient centricity, evidence generation to enable affordable access to medicines across markets, compassionate or special access programs, equitable participation in clinical trials, grants, and support programs, among others. In the ESG section of its 2022 published white paper on The Future of Medical Affairs 2030, the Medical Affairs Professional Society (MAPS) calls for medical teams “addressing the social determinants of health to broadly improve patient outcomes” [45].

2.2.1 Guided by Patient Centricity

A shift from a product focus to a patient focus, and adaptation of more patient-centric business structures and processes has become increasingly imperative for the pharmaceutical industry [46]. The change from a disease-centered to a patient-centered mindset and from a product-led to a patient-led development approach has been advocated previously by MA professionals as a necessary shift in cultural mindset in the modern business environment [47]. With the growing importance of patients and consumers as stakeholders, so has the MAs’ role in ensuring patient centricity is at the forefront of any initiative the industry undertakes [15].

Understanding and involvement in the patient journey, collaboration with patients and patient organizations through medical communication, evidence generation, and collaborative engagement of patients and associated family and care partners to support medical product development have become pillars of MA activities [48,49,50]. Similarly, in clinical research, patients are considered informed collaborators whose participation is ‘core’ to the overall success of trials [51]. In the concept of patient-centered drug development, patients play a pivotal role in all phases of drug development, where patient perspectives are considered throughout targeted product profiles, product design, study planning, design, and execution, as well as evidence reporting, knowledge translation and dissemination [47, 52, 53]. Patient-centered drug development also means including patient-reported outcomes (PROs) and other humanistic parameters in clinical development, and particularly in the earlier stages than the latter routine real-world/postmarketing settings. The benefits of early clinical phase inclusion of PROs go beyond complementing conventional efficacy and safety data; they are an opportunity to inform regulatory approvals, health policy, and clinical guidelines, to enhance future PRO strategies and future sample size calculations, as well as to provide preliminary efficacy data based on the patient experience and can help guide improvements in future clinical care [54].

In summary, MA activities are guided by patient centricity. This makes the functions valued partners primarily with external healthcare professionals since a common interest is shared.

2.2.2 Diversity, Equity and Inclusion in Clinical Research

In its April 2022 guidance on Diversity Plans to Improve Enrolment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry, the US FDA aims to enhance the diversity of clinical trial populations by recommending Race and Ethnicity Diversity Plans from sponsors of clinical trials seeking an investigational new drug or a biologics license application [55, 56].

In addition to clinical trial data generation, PROs need to be inclusive and equitable. The European Medicines Agency (EMA) is set to recommend the advancement of standards for clinical studies incorporating robust and meaningful patient experience data for regulatory submission [57, 58]. PROs are an important tool to demonstrate patients’ health-related quality of life, and the inclusion of underserved populations in PRO measures and data collection reflective of diverse and multicultural societies will improve research and promote equitable healthcare for the benefit of all patients and the broader public [59].

MA can ensure, via effective communication and its cross-functional involvement, that the advantages of diversity in clinical trials are understood and considered within organizations. In early study phases, diversity of trial subjects may improve the accuracy of key stop/go decisions and thus avoid later-phase studies on ineffective treatments, leading to cost savings. In addition, diverse patients enrolled may be more engaged and committed to staying in the study; thus, they could be followed up long-term, either in later trial phases, extensions, or real-world studies. Lastly, diversity will also result in an engagement opportunity for industry with investigators, research sites, patient advocates, and underrepresented communities [60].

2.2.3 Enabling Access to Medicines

Due to the challenges of managing increasing public health care expenditure, demand for evidence and justification of value are increasingly a requirement across global markets to support government funding and reimbursement decisions or price negotiation about new medicines and health technologies [61, 62].

The data-generation strategy has shifted here to an integrated approach that considers evidence required by payers in earlier clinical stages of development [63]. In particular, PROs and other real-world evidence (RWE) parameters generate value-based outcomes. These are regularly used in economic modeling and when establishing pricing for new therapeutic interventions, and as such are relevant to a Health Technology Assessment (HTA) by which payers judge if a new drug is cost effective in their healthcare system [64].

Evidence generation, and especially RWE generation, are core to the MA function, mostly in close alignment with market access/health economics and outcome research (HEOR) and other relevant functions (epidemiology, pharmacovigilance, etc.), ensuring the voice of the patient is heard and incorporated into evidence generation while simultaneously improving the standard and rigor [15, 65].

Access to unlicensed or otherwise unavailable or inaccessible (e.g., unfunded) potentially life-saving medicines through compassionate use programs (CUP), early access programs (EAPs) or other special access schemes, is usually governed and supervised by the clinical development and MA functions [65, 66]. Despite various individual country-specific regulatory differences in the set-up, these programs and clinical trials generally provide free-of-charge prelaunch access to unapproved drugs [67]. The programs allow the companies and physicians to meet the needs of patients with serious or rare diseases by providing potentially life‑saving medicines via a controlled mechanism of access and may generate additional value via the development of positive relationships with key opinion leaders (KOLs), patients, and regulators [68]. This can build an advocacy base for the product and provides an opportunity for early penetration into the market during pre-launch, as well as increased acceptance and uptake by physicians and patients after the commercial launch of the product [69, 70]. Finally, MA can proactively generate meaningful, RWE from such programs, despite their inherent challenges (lack of standardization, heterogeneity, confounding variables, etc.) [71,72,73,74].

2.2.4 Grants and Support Programs

Requests and applications for medical education grants, research grants, charitable contributions, funding support and other support programs are usually assessed and approved by MA within the compliance framework and other applicable guidelines and policies [15, 75]. Educational grants are given to support bona fide activities, ensuring independence, and decoupling from objectives related to product sales and promotion, whereas research grants are not only direct funding but can also constitute supply of a company’s product free of charge or other support for the purpose of advancing knowledge via evidence generation [76]. Financial support enables health care organizations and patient advocacy groups to grow their operations, cover administration costs and pursue activities such as education, research funding and advocacy [77]. Charitable contributions and business donations range from disaster relief to providing community medical services, improving the quality and availability of healthcare [78].

Those contributions serve additional beneficial purposes for the industry, such as collaboration with researchers, academia and health care organizations, product enhancement through additional evidence generation, disease awareness, etc. Industry contributions not only support the advancement of research and innovation but also have broader merit towards public health and healthcare infrastructure, as companies are involved in actions that consider the well-being of society [42]. Favorable public views of these activities have been reported among US consumers in 2020, with 62% stating they would view an organization more positively if it takes action to address social determinants of health—essentially actions in the social pillar of ESG [44].

2.3 Governance

The pharmaceutical industry governance model links business considerations with its ESG framework and ensures engagement and alignment from senior leadership with its cross-functional governing committees and independent oversight. Leadership commitment on governance focuses on aspects related to business ethics, promotional practices, anti-bribery and anti-corruption, integrity, compliance, gender diversity, quality framework and standards, and, among others, a commitment to patient safety [78,79,80,81,82]. However, adequate, and effective corporate governance has been called out for higher disclosure quality and transparency [83].

The MA function ensures adherence to standards of accountability, ethics, and compliance, as well as transparency. This is done through core MA competencies that can withhold audit scrutiny in policy governed areas of external engagements (non-promotional), medical information query resolution, review of promotional activities and grants, ensuring the quality use of medicines, conduct of clinical research, and transparency reporting [15, 65, 84].

2.3.1 Quality Use of Medicines

From the experiences of the COVID-19 pandemic, medicine accessibility and supply were challenged globally, putting patients’ lives at risk [85,86,87]. During the pandemic, the use of experimental medicines has not been uncommon, be it the repurposing of established drugs, off-label use or compassionate requests, yet only MA can respond to unsolicited off-label enquiries as per common governance [15, 16, 88, 89].

Well-recognized gaps in the prescription and use of medicines, for example high prescribing rates of antibiotics leading to antimicrobial resistance, or opioid prescribing with insufficient restrictions resulting in misuse and addiction, have led to initiatives aimed at quality use of medicines, improving the standards of prescribing, and taking proactive measures to ensure medicines are used correctly in the right patients. Within the industry, the quality use of medicines is ensured by MA in collaboration with other functions. Here, the leading role of MA is to ensure proper and safe use of medicines through medical education, via ensuring information to the external audience is accurate, balanced, and substantiated, initiatives to improve patient adherence and persistence, for example, via patient support programs or patient and caregiver education, and lastly, via meaningful data generation as a fundament for these activities. Taking antimicrobial stewardship (AMS) and industry’s role as an example, MA provides AMS awareness and education, facilitates research and AMS surveillance (especially via global programs for identifying resistance trends), facilitates patient-centered AMS program implementation, generates treatment decision support tools, and establishes advocacy with infectious disease societies, patient groups, and other partners to enable appropriate patient access to novel antibiotics [90].

2.3.2 Continuous Medical Education

CME under the governance of MA results in better clinical outcomes for patients and improved physician performance, and thus linking the provision of such back to patient centricity [91,92,93]. Principles of quality-based medical education range from ethical, transparent and responsible engagement to needs-based, up-to-date, balanced and objective content as well as robust and standardized pro